BD Announces FDA 510(k) Submission of Two Hour Test to Identify Superbug in Patients with Positive Blood Cultures
First Molecular Test to Simultaneously Identify Methicillin-Sensitive and Methicillin-Resistant Staphylococcus aureus in Patients with Positive Blood Cultures
SAN DIEGO, April 25 /PRNewswire-FirstCall/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today that it has submitted to the U.S. Food and Drug Administration (FDA), for 510(k) clearance, the first assay for the rapid and simultaneous identification of methicillin-sensitive Staphylococcus aureus (MSSA) and methicillin-resistant Staphylococcus aureus (MRSA) from patients with positive blood cultures. This assay will enable physicians to implement the right treatment at the right time for patients with bloodstream infections, transforming patient care and significantly reducing healthcare costs.
The BD GeneOhm(TM) StaphSR assay is a fast, simple test that is performed directly from positive blood cultures. The assay requires less technologist time and provides results within two hours compared to over two days for traditional microbiology algorithms. Studies have shown that providing physicians with important microbiology information earlier results in decreased mortality, length of stay and variable costs.
The BD GeneOhm StaphSR assay promotes faster, better antibiotic selection to assist in preventing the emergence of vancomycin-resistant organisms, such as vancomycin-resistant Staphylococcus aureus (VRSA).
"The FDA submission of the BD GeneOhm StaphSR assay is another important step toward BD's commitment to help our customers rapidly identify, prevent, and control healthcare-associated infections (HAIs)," commented William Kozy, Executive Vice-President, BD. "Currently, the BD GeneOhm(TM) MRSA assay rapidly identifies patients that are colonized with MRSA and allows infection control professionals to break the chain of MRSA transmission earlier. Traditional culture techniques identify patients colonized with MRSA in two to three days, increasing the opportunity for transmission of this dangerous organism. We plan on making additional submissions to the FDA for wound and nasal swab claims with the BD GeneOhm StaphSR assay. We are also developing rapid tests for the detection of the vanA and vanB genes associated with vancomycin-resistant enterococci (VRE), as well as a rapid assay for the identification of Clostridium difficile (C. Diff.). VRE and C. Diff. are two other troublesome organisms causing severe HAIs."
BD, a leading global medical technology company that manufactures and sells medical devices, instrument systems and reagents, is dedicated to improving people's health throughout the world. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The Company's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 27,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. For more information, please visit www.bd.com.
This press release contains certain estimates and other forward-looking statements (as defined under Federal securities laws) regarding BD's performance, including future performance, products or other events or developments that BD expects to occur or anticipates occurring in the future. All such statements are based upon current expectations of BD and involve a number of business risks and uncertainties. Actual results could vary materially from anticipated results described, implied or projected in any forward-looking statement. Factors that could cause actual results to vary materially from any forward-looking statement include, but are not limited to: competitive factors; pricing and market share pressures; difficulties inherent in product development and delays in product introductions; changes in regional, national or foreign economic conditions; increases in energy costs and their effect on, among other things, the cost of producing BD's products; fluctuations in costs and availability of raw materials and in BD's ability to maintain favorable supplier arrangements and relationships; changes in healthcare or other governmental regulation; as well as other factors discussed in this press release and in BD's filings with the Securities and Exchange Commission. We do not intend to update any forward-looking statements to reflect events or circumstances after the date hereof except as required by applicable laws or regulations.
SOURCE BD (Becton, Dickinson and Company)
Released April 25, 2007